4种常见呼吸系统疾病治疗药物的体外雾化特性评价

Evaluation of in vitro Nebulization Characteristics of 4 Drugs for Respiratory Diseases

目的研究盐酸戊乙奎醚注射液、硫酸庆大霉素注射液、地塞米松磷酸钠注射液和盐酸氨溴索注射液的雾化质量特性,以吸入用盐酸氨溴索溶液为阳性对照,评估此4种注射液雾化吸入的可行性。方法测定物理化学性质(pH、表面张力、渗透压)、递送速率和递送总量(呼吸模拟器)、空气动力学粒径分布(药用撞击器和喷射雾化器系统),并通过参数微细粒子剂量、微细粒子分数、质量中值空气动力学粒径和几何标准偏差对空气动力学粒径分布进行描述。结果盐酸戊乙奎醚注射液、硫酸庆大霉素注射液、地塞米松磷酸钠注射液、盐酸氨溴索注射液和吸入用盐酸氨溴索溶液的递送速率分别为:(0.010±0.002)、(1.171±0.170)、(0.104±0.009)、(0.564±0.114)和(0.398±0.049)mg·min-1,对应的递送总量:(0.189±0.017)、(18.532±1.240)、(1.538±0.006)、(4.264±0.299)和(3.835±0.019)mg;质量中值空气动力学粒径:(4.953±0.241)、(4.577±0.685)、(6.458±0.535)、(4.666±0.190)和(4.931±0.051)μm,微细粒子分数:(50.589±2.494)%、(53.487±7.058)%、(24.523±12.140)%、(53.224±2.127)%和(50.700±0.536)%。结论盐酸戊乙奎醚注射液、硫酸庆大霉素注射液、盐酸氨溴索注射液具备一定的雾化给药特性,而地塞米松磷酸钠注射液的雾化效果不佳。

OBJECTIVE To evaluate the feasibility inhaled atomized penehyclidine hydrochloride injection,gentamycin sulfate injection,dexamethasone sodium phosphate injection,and ambroxol hydrochloride injection through study the nebulization characteristics of these four injections,and the nebulization characteristics of ambroxol hydrochloride solution for inhalation were used as a positive control.METHODS Firstly,the physicochemical properties of the four kinds of injection were measured,including pH,surface tension,and osmolality.Then,the delivery rate and the total delivery amount of each injection were determined by the respiratory simulator.The aerodynamicparticle size distribution of each injection was studied by the next generation impactor.Fine particle dose,fine particle fraction,mass median aerodynamic diameter,and geometric standard deviation were used to describe the aerodynamic particle size distribution.RESULTS The delivery rate of penehyclidine hydrochloride injection,gentamycin sulfate injection,dexamethasone sodium phosphate injection,ambroxol hydrochloride injection,and ambroxol hydrochloride solution for inhalation was(0.010±0.002),(1.171±0.170),(0.104±0.009),(0.564±0.114),and(0.398±0.049)mg·min-1;total delivery amounts were(0.189±0.017),(18.532±1.240),(1.538±0.006),(4.264±0.299),and(3.835±0.019)mg.Mass median aerodynamic diameter was(4.953±0.241),(4.577±0.685),(6.458±0.535),(4.666±0.190),and(4.931±0.051)μm.Fine particle fraction was(50.589±2.494)%,(53.487±7.058)%,(24.523±12.140)%,(53.224±2.127)%,and(50.700±0.536)%.CONCLUSION Penehyclidine hydrochloride injection,gentamicin sulfate injection,and ambroxol hydrochloride injection represent acceptable nebulization characteristics,but dexamethasone sodium phosphate injections can not exhibit good nebulization characteristics.